510(k) Report

Devices descending from K181642

8 later devices reach B-Laser Atherectomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212047Pantheris SystemAvinger, Inc.20210—
+1K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+2K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+2K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+3K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+4K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+5K260244Auryon Atherectomy SystemEximo Medical20260—
+5K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401